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Immunocore and Argenx Among Fast-Track Hopefuls At EMA

Five Accelerated Assessment Decisions Due, Including On Tebentafusp And Efgartigimod

 
• By Maureen Kenny

EU reviewers will decide this week whether to grant accelerated assessment to a handful of new dug candidates that will soon be filed for approval.

Competitive Advantage Blocks With One Arrow
Getting A New Product To Market Faster Can Give Companies A Competitive Advantage • Source: Alamy

Immunocore should find out this week whether its investigational immunotherapy and lead drug candidate, tebentafusp, will be fast-tracked through the EU review process when the company files for approval. Tebentafusp is a potential treatment for patients with previously untreated metastatic uveal melanoma, a rare and aggressive cancer of the eye. 

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More from Europe

More from Geography

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.